OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 21:18:41

Label at a glance#

ProductOmeprazole

Active ingredientOMEPRAZOLE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-759-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 10 mg

R_xonly

100 Capsules

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

R_xonly

100 Capsules

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

R_xonly

100 Capsules

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	11
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	11
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	11
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	11
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	11
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OMEPRAZOLE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-759-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	11
65841-759-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	11
65841-759-06	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	11
65841-759-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	11
65841-759-16	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	11
65841-760-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	11
65841-760-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	11
65841-760-06	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	11
65841-760-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	11
65841-760-16	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	11
65841-761-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	11
65841-761-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	11
65841-761-06	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	11
65841-761-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	11
65841-761-16	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-759	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 5 package rows	20241206_2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2.zip
65841-760	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 5 package rows	20241206_2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2.zip
65841-761	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 5 package rows	20241206_2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	1
ACETONE	INACTIVE INGREDIENT	1364PS73AF	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	INACTIVE INGREDIENT	8LDD2V82F5	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

Omeprazole
ACETONE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 3
FERROSOFERRIC OXIDE
GELATIN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-759	65841-759-06, 65841-759-16, 65841-759-01, 65841-759-05, 65841-759-10
65841-760	65841-760-06, 65841-760-16, 65841-760-01, 65841-760-05, 65841-760-10
65841-761	65841-761-06, 65841-761-16, 65841-761-01, 65841-761-05, 65841-761-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMEPRAZOLE	KG60484QX9	ACTIB
ACETONE	1364PS73AF	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 3	PN2ZH5LOQY	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	94255I6E2T	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
OMEPRAZOLE	KG60484QX9	ACTIB
ACETONE	1364PS73AF	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	94255I6E2T	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 270 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
ACETONE	ACETONE	1364PS73AF	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
ACETONE	ACETONE	1364PS73AF	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	8LDD2V82F5	CAPSULE, DELAYED RELEASE / ORAL		129 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
ACETONE	ACETONE	1364PS73AF	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	94255I6E2T	CAPSULE, DELAYED RELEASE / ORAL		18 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii+route+dosage form 18 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091352-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091352-001	AB
A091352-002	AB
A091352-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091352-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091352-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091352-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091352-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	AB	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Zydus Lifesciences Limited	2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2	2024-12-03		Exact identifier ndc (package): 65841-760-16 ndc (package): 65841-760-01 ndc (package): 65841-759-05 ndc (package): 65841-759-06 ndc (package): 65841-759-01 ndc (package): 65841-759-16 ndc (package): 65841-759-10 ndc (package): 65841-761-05 ndc (package): 65841-760-06 ndc (package): 65841-761-01 ndc (package): 65841-761-16 ndc (package): 65841-761-06 ndc (package): 65841-760-10 ndc (package): 65841-760-05 ndc (package): 65841-761-10 ndc (product): 65841-761 ndc (product): 65841-759 ndc (product): 65841-760 ndc11 (package): 65841075905 ndc11 (package): 65841075901 ndc11 (package): 65841076001 ndc11 (package): 65841076106 ndc11 (package): 65841075906 ndc11 (package): 65841076010 ndc11 (package): 65841076005 ndc11 (package): 65841075910 ndc11 (package): 65841076016 ndc11 (package): 65841076101 ndc11 (package): 65841076006 ndc11 (package): 65841075916 ndc11 (package): 65841076105 ndc11 (package): 65841076110 ndc11 (package): 65841076116 spl id: 691b64ae-e6ff-4a10-9973-886901529db0 spl set id: 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.